Vaginal Dilators for Prevention of Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Antosh, Danielle D. MD; Gutman, Robert E. MD; Park, Amy J. MD; Sokol, Andrew I. MD; Peterson, Joanna L. RN; Kingsberg, Sheryl A. PhD; Iglesia, Cheryl B. MD

Obstetrics & Gynecology:
doi: 10.1097/AOG.0b013e3182932ce2
Original Research
Abstract

OBJECTIVE: To compare rates of de novo dyspareunia in women with and without vaginal dilator use after posterior colporrhaphy.

METHODS: This randomized controlled trial included sexually active patients with prolapse and no bothersome baseline dyspareunia undergoing posterior colporrhaphy. Patients were randomized to daily vaginal dilator use from postoperative weeks 4 through 8 or to no dilator use. Pelvic organ prolapse quantification examination and vaginal caliber were measured at baseline, 8 weeks, and 6 months postoperatively. Sexual function was evaluated at baseline, 3 months, and 6 months postoperatively using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12. Participants completed a Patient Global Impression of Improvement at 3 months and 6 months postoperatively.

RESULTS: Sixty patients were randomized: 30 in the dilator group and 30 in the control group. There were no differences in baseline characteristics and postoperative vaginal caliber between groups. At 3 months, 9.5% of patients reported de novo dyspareunia in the dilator group compared with 19.2% of control patients (P=.44). At 6 months, 12.5% of patients in the dilator group reported de novo dyspareunia compared with 3.8% of control patients (P=.34). There was a 13% loss-to-follow-up rate, and therefore we did not meet appropriate power to detect a difference. There were no differences in overall sexual function or Patient Global Impression of Improvement scores between groups at 3 months and 6 months.

CONCLUSION: There were no significant differences in de novo dyspareunia rates, overall postoperative sexual function scores, or global improvement scores between those using vaginal dilators compared with control patients.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01299363.

LEVEL OF EVIDENCE: I

In Brief

Postoperative sexual function scores and de novo dyspareunia rates are similar between women with and without vaginal dilator use after posterior colporrhaphy.

Author Information

Department of Obstetrics and Gynecology, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, Washington, DC; and the Departments of Reproductive Biology and Psychiatry, Division of Behavioral Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Corresponding author: Danielle D. Antosh, MD, The Methodist Hospital; Center for Restorative Pelvic Medicine; 6560 Fannin, Suite 2100, Houston, TX 77030; e-mail: ddantosh@tmhs.org.

Funded by the American Congress of Obstetricians and Gynecologists Boehringer Ingelheim Pharmaceuticals Inc Research Award in Female Sexual Dysfunction.

Financial Disclosure Dr. Kingsberg is a consultant for BioSante, NorvoNordisk, Pfizer, Viveve, Trimel, Palatin, Sprout, and Shinogi. The other authors did not report any potential conflicts of interest.

Presented at the American Urogynecologic Society 33rd Annual Scientific Meeting, October 3–6, 2012, Chicago, Illinois.

© 2013 The American College of Obstetricians and Gynecologists